Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population; (EKBB 236/13) (EMERGE IV)

Triage - Symptoms and Other Predictors in an All-comer Emergency Department Population (EMERGE IV)

This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

Study Overview

Detailed Description

Most Emergency Departments (EDs) perform an initial risk stratification of patients, called Triage. Establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. The earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. New ways to improve diagnosis accuracy early on in patients' ED visits are needed. Although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. Most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints.

This study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. Based on vital signs, impaired mobility on presentation (IMOP), Clinical Frailty Scale (CFS) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

According to acuity patients undergo triage or directly proceed to the treatment unit. Patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. Afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. Patients in need of immediate therapy will receive therapy before start of the interview. Following the interview, patients undergo routine triage.The physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). Treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. Follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.

Study Type

Observational

Enrollment (Actual)

7309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland, 4031
        • Department of Emergency Medicine, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to the ED of the University Hospital Basel over a time-course of 9 weeks from 25.03.2019 to 27.05.2019.

Description

Inclusion Criteria:

  • patients presenting to the ED of the University Hospital Basel and awaiting triage

Exclusion Criteria:

  • unwillingness to participate
  • insufficient ability to communicate with the study personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients admitted to emergency ward
all patients admitted to the emergency ward and awaiting triage are observed
Questionnaire with a predefined list of 35 symptoms
Exploratory interview assessing reason for patient presentation at ED
numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)
Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)
Assessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill
Assessment of IMOP: defined as being unable to stand unaided or walk without help
Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: within 30 days of the day of presentation to the ED
30-day mortality is defined as death within 30 days of the day of presentation to the ED
within 30 days of the day of presentation to the ED

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death rate (In-hospital mortality)
Time Frame: from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)
In-hospital mortality is defined as death occurring during presentation to the ED and hospital discharge
from day of presentation to the ED to day of hospital discharge (assessed within 365 days of the day of presentation to the ED)
Number of hospitalizations
Time Frame: day of presentation to the ED
Hospitalization is defined as the direct admission from the ED to any hospital in-patient department with a stay of over 24 hours
day of presentation to the ED
Number of ICU-admissions
Time Frame: day of presentation to the ED
ICU-admission is defined as any direct admission to the ICU of the University Hospital of Basel
day of presentation to the ED
Number of institutionalisations
Time Frame: within 365 days of the day of presentation to the ED
Institutionalisation is defined as no time spent at home during 365 days following presentation
within 365 days of the day of presentation to the ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roland Bingisser, Prof. Dr., Department of Emergency Medicine, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB_2019_00008; me19Bingisser

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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